Version May 2016
Table of Contents 1. Introduction... 3 1.1. Context... 3 1.2. General objectives... 4 1.3. The scope of the Code... 5 2. Glossary... 6 2.1. Definitions laid down in Regulation (EC) No 767/2009... 6 2.2. Other definitions... 7 3. Typology of labelling particular... 8 3.1. Product information provided through labelling... 8 3.1.1. Traceability related information... 8 3.1.2. Instructions for use...10 3.1.3 Compound feed specifications...12 3.2. Information available on purchaser s request...18 3.2.1 Quantitative declaration of feed materials...18 3.2.2 Declaration of feed additives other than those subject to mandatory labelling requirements...19 4. Listing and specificity of commonly used labelling media... 200 4.1. General principles...20 4.2. Design of the label...20 4.3. Additional documents or media (paper, internet, telephone )...21 4.4. Distance selling...21 Annexes.... 22 Annex I: Management of claims. 23 1. Guidance on the implementation of Article 13 and Article 11 b) of Regulation (EC) No 767/2009 on claims...23 1.1. Basic conditions for use of a claim...23 1.2. Basic description of a claim...23 1.3. Phrasing of a claim...24 1.4. Basic approach on substantiation of a claim...25 1
1.5. Typology of claims...25 1.5.1. Nutritional and compositional claims...25 1.5.2. Functional claims...26 1.5.3. Livestock management claims...27 1.5.4. Prohibited claims...28 2. Substantiation of claims...29 2.1. Substantiation of a claim...29 2.2. Evidence suggested per type of claims...29 2.2.1. General principles... 269 2.2.2. Specific requirements for compositional claims...30 2.2.3. Specific requirements for functional and livestock management claims...31 3. Methodology for compiling an evidence file...33 3.1. Conditions for carrying out and validating studies...32 3.2. Experimental protocol...33 Annex II: Summary table on labelling particulars to be disclosed on the labelling...35 Annex III: Best practice recommendation for legibility of a label...37 Annex IV: Guidance on the obligation to make available information on quantitative composition data on purchaser s request...41 Annex V: Guidance for the declaration of methionine under the analytical constituents heading in case of addition of MHA...43 2
1. Introduction 1.1. Context New European Union rules on the placing on the market and use of feed (Regulation (EC) No 767/2009, hereafter referred to as the Regulation ) are applicable from 1 September 2010. Articles 25 and 26 of the Regulation introduce a provision to encourage representatives of European feed business sectors to develop a Code of good labelling practice for compound feed for food-producing animals. The European Feed Manufacturers' Federation (FEFAC) and the organisation representing European farmers and European agricultural cooperatives (Copa-Cogeca) have jointly developed a Code of good labelling practice for compound feed for food producing animals (hereafter referred to as the Code ). The authors believe that putting together many of the legal provisions for the labelling of feed materials and compound feed for animals in the Regulation represents major progress when compared to former legislation. These new rules give feed business operators greater responsibility and aim to modernise and harmonise labelling conditions and procedures. The authors believe that labelling practices and procedures should meet the following objectives: - Provide useful information and most importantly facilitate proper use of the product. - Have the capacity to match the specific requirements of the purchasers and users of the product, including farmers - Remain flexible enough to enable innovation and allow manufacturers to differentiate their products in a competitive environment. This jointly developed Code aims to achieve these goals while conforming to the general objectives and specific provisions of the Regulation. To achieve this, the Code has drawn on the skills and expertise of representatives directly involved in the European animal feed sectors along with the users and purchasers of compound feed. The Code aims to represent the interests of these different categories of operators. The Code was developed using the procedure included in Article 26 of the Regulation, including consultation of relevant EU feed chain stakeholder organisations, before being submitted for examination by the European Commission, according to the advisory procedure detailed in Article 28, paragraph 2 of the Regulation document. The Code was then made openly available for public comment for a period of one month. The original version was submitted to the European Commission only in English. Translation into other EU languages is under the exclusive responsibilities of Copa-Cogeca and FEFAC Member Organisations. 3
The Code applies to all operators in the compound feed sector who are established in the European Union. The references of the Code are published in the Official Journal of the European Union (No C..., page...). Any future changes to the current Code will be made by the aforementioned organisations using the same procedure outlined in Article 26 of the Regulation. The Code will be reviewed as required to take into account technical adaptation of the legislation, or at least every two years. 1.2. General objectives The Code aims to facilitate the labelling of compound feed for food producing animals (in bulk or packed) which is placed on the European market and ensure that information essential for the farmer is appropriately displayed on the label. The Code includes some practical advice aiming to make it easier for those responsible for labelling compound feeds. The Code clarifies legal requirements of the Regulation relating to the labelling of compound feed: including the content and type of information that the compound feed manufacturer / supplier must provide to the purchaser. This has particular relevance on the type of product composition information that manufacturers / suppliers may need to supply upon request from the purchaser. The Code also provides guidance on traceability-related labelling particulars to ensure easy identification of the product, its supplier and/or its manufacturer. The Code aims to provide farmers with the information necessary for them to make an informed choice on which products are best suited to their needs. The authors therefore aimed to ensure that particular attention is paid to voluntary labelling as one of the priority areas for improving the quality of labelling. They believe that this new element (which was introduced by the EU legislator and was included in Articles 22 and 25 of the Regulation) constitutes major progress. It is very important that operators make full use of the options that have been opened up by this new legislation on voluntary labelling. The Code aims to provide suggestions as to the type of particulars that could be disclosed on a voluntary basis to encourage operators to provide any further information if they wish to do so. The authors believe that this includes information on the nutritional value of the compound feed which is not required by law. Such details may include energy values, the total trace-element content, protein value, crude ash content for mineral feed, phosphorus content for complementary feeds, the presence of certain additives and/or other additional voluntary labelling information deemed relevant to understand the nutritional quality of the specific compound feed. The Code aims to guarantee an appropriate level of information for farmers whilst also protecting and preserving the competitiveness of their suppliers (whether they are private trade partners or cooperatives producing compound feed) by using the relevant aspects of intellectual property law. These concerns are linked in particular to the disclosure of 4
inclusion rates of feed materials on a voluntary basis or upon request of the purchaser. The Code also provides further guidance on how to interpret and apply the new legislative framework on claims as referred to in Article 13 of Regulation (EC) No 767/2009 in order to ensure that such claims are meaningful and to allow the purchaser to use the compound feed in an optimised way. Further information regarding the type of claims, their substantiation as well as their phrasing is also provided in the Code. Finally, the authors believe that the form and type of labelling used is a very important factor in ensuring that the information is clearly understood by the farmer. Labelling should reflect and move with the developments in market communication by being able to take into account techniques such as the use of electronic media and the internet. 1.3. The scope of the Code As far as the use and the placing on the market of compound feed are concerned, the Code focuses on the provisions included in the Regulation. In addition to this, further legislation must be complied with by the manufacturer and the user must also be aware of these. Non-exhaustive examples of such legislation includes, Regulation (EC) No 178/2002 on General Food Law, Regulation (EC) No 1831/2003 on additives for use in animal nutrition, Directive 2008/38/EC establishing a list of intended uses of animal feedingstuffs for particular nutritional purposes, Regulation (EC) No 999/2001 laying down rules for the prevention, control and eradication of certain TSEs, Regulation (EC) No 1069/2009 and Regulation (EC) No 142/2011 on animal by-products and Regulations (EC) No 1829/2003 on GM food & feed and (EC) No 1830/2003 on traceability and labelling of GM food & feed. It should be noted that this Code does not apply to feed materials, compound feed for household pets, compound feed for fur animals, feed additives or premixtures of feed additives, which are subject to specific labelling provisions. It applies to medicated feed, without prejudice to specific labelling requirements defined in Directive 90/167/EEC, and to feed destined to organic farming, without prejudice to specific labelling requirements defined in Regulations (EC) No 834/2007 and (EC) No 889/2008. 5
2. Glossary 2.1. Definitions laid down in Regulation (EC) No767/2009 The definitions of feed-business operator, food-producing animal, feed materials, compound feed, complete feed, complementary feed, mineral feed, milk replacer, carrier, particular nutritional purpose, feed intended for particular nutritional purposes, minimum storage life, batch or lot, labelling, label, and presentation are laid down in Article 3(2) of Regulation (EC) No 767/2009. feed-business operator food-producing animal feed materials compound feed complete feed complementary feed mineral feed milk replacer carrier any natural or legal person responsible for ensuring that the requirements of this Regulation are met within the feed business under their control. any animal that is fed, bred or kept for the production of food for human consumption, including animals that are not used for human consumption, but that belong to a species that is normally used for human consumption in the Community. products of vegetable or animal origin, whose principal purpose is to meet animals nutritional needs, in their natural state, fresh or preserved, and products derived from the industrial processing thereof, and organic or inorganic substances, whether or not containing feed additives, which are intended for use in oral animal-feeding either directly as such, or after processing, or in the preparation of compound feed, or as carrier of premixtures. a mixture of at least two feed materials, whether or not containing feed additives, for oral animal-feeding in the form of complete or complementary feed. compound feed which, by reason of its composition, is sufficient for a daily ration. compound feed which has a high content of certain substances but which, by reason of its composition, is sufficient for a daily ration only if used in combination with other feed. complementary feed containing at least 40 % crude ash. compound feed administered in dry form or after dilution in a given quantity of liquid for feeding young animals as a complement to, or substitute for, postcolostral milk or for feeding young animals such as calves, lambs or kids intended for slaughter. a substance used to dissolve, dilute, disperse or otherwise physically modify a feed additive in order to facilitate its handling, application or use without altering its technological function and without exerting any technological effect itself. 6
particular nutritional purpose feed intended for particular nutritional purposes minimum storage life batch or lot labelling label presentation the purpose of meeting the specific nutritional needs of animals whose process of assimilation, absorption or metabolism is, or could be, temporarily or irreversibly impaired and who can therefore benefit from the ingestion of feed appropriate to their condition. feed which can satisfy a particular nutritional purpose by virtue of its particular composition or method of manufacture, which clearly distinguishes it from ordinary feed. Feed intended for particular nutritional purposes does not include medicated feedingstuffs within the meaning of Directive 90/167/EEC. the period during which, under proper storage conditions, the person responsible for the labelling guarantees that the feed retains its declared properties; only one minimum storage life may be indicated in respect of the feed as a whole, and it is determined on the basis of the minimum storage life of each of its components. an identifiable quantity of feed determined to have common characteristics, such as origin, variety, type of packaging, packer, consignor or labelling, and, in the case of a production process, a unit of production from a single plant using uniform production parameters or a number of such units, when produced in continuous order and stored together. the attribution of any words, particulars, trade marks, brand name, pictorial matter or symbol to a feed by placing this information on any medium referring to or accompanying such feed, such as packaging, container, notice, label, document, ring, collar or the Internet, including for advertising purposes. any tag, brand, mark, pictorial or other descriptive matter, written, printed, stencilled, marked, embossed, impressed on, or attached to the packaging or the container of feed. the shape, appearance or packaging and the packaging materials used for the feed, further to the way in which it is arranged and the setting in which it is displayed. 2.2. Other definitions The definitions of 'feed, feed business and placing on the market are laid down in Article 3 of Regulation (EC) No 178/2002. The definitions of feed additive, premixture, processing aids and daily ration are laid down in Article 2 of Regulation (EC) No 1831/2003. The definitions of establishment and competent authority are laid down in Article 3 of Regulation (EC) No 183/2005. The definitions of animal species or animal categories are laid down in Annex IV to Commission Regulation (EC) No 429/2008. 7
3. Typology of labelling particular 3.1. Product information provided through labelling 3.1.1. Traceability related information Commercial name of the product: The person responsible for the labelling may mention on the label the commercial name of the compound feed. This may also be accompanied by a unique identification number to ensure traceability and correct use of products. The commercial name of the product should not mislead the user as regards the intended uses and characteristics of the product and should always respect the general principles as well as the provisions on claims. Type of compound feed Indicate the description of the type of compound feed: complete feed or complementary feed, as appropriate - For complete feed, the designation complete milk replacer feed may be used, if appropriate, - For complementary feed, the following designations may be used if appropriate: mineral feed or complementary milk replacer feed. Indicate the animal categories or by default, species for which the compound feed is destined to. It is recommended to combine the description of the type of compound feed and the species of destination (e.g. complete feed for turkey). For dietetic feed, the qualifying expression dietetic should be mentioned next to the designation of the feed (e.g. dietetic complete feed). Identification of the feed business operator responsible for the labelling The person responsible for the labelling shall be the feed business operator who first places compound feed on the market or, where applicable, the feed business operator under whose name or business name the feed is marketed. This means that a retailer placing a compound feed on the market under its name is responsible for all the labelling particulars. In any case, the person responsible for labelling shall be established in the European Union. R. 767/2009, Art 11(1) R. 767/2009, Art 13 R. 767/2009, Art 15(a) R. 767/2009, Art. 17, 1 (a) R. 767/2009, Art. 12 8
Shall be specified on the label: - The name or business name of the person responsible for labelling; - If the person responsible for labelling holds approval as a feed establishment in accordance with article 10 of Regulation (EC) No 183/2005 on feed hygiene, this approval number; - If the person responsible for labelling does not hold approval as a feed establishment but holds an approval granted in accordance with Article 24 of Regulation (EC) No 1069/2009 on animal by-products 1, this approval number. R. 767/2009, Art. 15 (b) R. 767/2009, Art. 15 (c) For the sake of traceability, a company that has an approval number for the production of certain feeds (e.g. production of feed containing coccidiostats) should also specify this approval number on the label of other types of feed they are producing but which do not require an approval (e.g. production of a grain mixture for ornamental birds without additives). In cases where the producer is not the person responsible for the labelling, the following shall be provided in addition to the above labelling particulars: - The name and address of the producer or business name, or - An identifying number which shall be: o The approval number of the producer for approved feed manufacturers in accordance with article 10 of Regulation (EC) No 183/2005; o By default, an identifying number in accordance with Articles 9, 23 or 24 of Regulation (EC) No 183/2005; o By default, an identifying number allocated at the request of the producers or the importing feed business operator, which shall be in accordance with the format laid down in Chapter II of Annex V to Regulation (EC) No 183/2005. R. 767/2009, Art. 17 (c) Batch or lot reference number A batch (also called a lot) is an identifiable quantity of feed determined to have common characteristics (such as composition, species of destination, packer or labelling). In the case of compound feed, the batch number shall refer uniquely to a unit of production from a single plant using uniform production parameters (such as same formulation, presentation) or a R. 767/2009, Art. 15 (d) 1 It must be stressed that Regulation (EC) No 767/2009 refers to Regulation (EC) No 1774/2002 on Animal-By-Products, which has been replaced in the meantime by Regulation (EC) No 1069/2009 and Regulation (EC) No 142/2011. For the purpose of the indication of approval numbers related to the Animal-By-Products legislation, the correspondence between the relevant articles of Regulation (EC) No 1774/2002 and Regulation (EC) No 1069/2009 is based in particular on the Correlation Table in Annex of Regulation (EC) No 1069/2009). 9
number of such units, when produced in continuous order and stored together. The purpose of the indication of the batch number on the label is to facilitate the traceability of the product placed on the market. The determination of the size and characteristics of the batch shall be established as part of the traceability system designed by the manufacturer as required under Annex II of the EU Feed Hygiene Regulation (EC) No 183/2005. The format of the batch number is left to the manufacturer. It is recommended that the elements making up the batch number are meaningful to allow ease of identification. Net quantity The net quantity expressed in units of mass in the case of solid products, and in units of mass or volume in the case of liquids. R. 767/2009, Art. 15 (e) 3.1.2. Instructions for use a) General instruction for proper and appropriate use: The labelling of all types of compound feed shall also include the general instructions for proper and appropriate use, indicating the purpose for which the compound feed is intended and when required by the legislation, animal categories or species to which the compound feed must not legally be fed. Attention should be paid to the existence of specific instructions for use linked to the presence of certain feed additives / feed materials: - For compound feed containing certain additives for which legal instructions are mentioned in the authorisation decision (e.g. for coccidiostats or copper), please refer to the legal act authorising the feed additive, accessible via the Community register of feed additives. - For compound feed containing coccidiostats and histomonostats, draw attention to the obligation to ensure a withdrawal period before slaughtering or placing on the market of the food of animal origin as specified in the legal act authorising the feed additive. - For compound feed containing feed materials of animal origin where its use is subject to restrictive conditions (e.g. nonruminant PAPs, fishmeal, blood meal or blood products), the nature of the feed materials included and the species for which the use of the feed is prohibited shall be specified on the label (for example: contains processed animal protein derived from non-ruminants shall not be fed to farmed R. 767/2009, Art. 17(b) R. 999/2001, Annex IV, chapter IV 10
animals except aquaculture animals and fur animals ). For complementary feed containing additives in excess of the maximum levels fixed for complete feed, specify the maximum quantity of the complementary feed: - in grams or kilograms or units of volume of complementary feed per animal per day, or - percentage of the daily ration based on 12% moisture content, or - per kilo of complete feed or percentage in complete feed, in order to ensure that the respective maximum contents of feed additives in the daily ration are complied with. For dietetic feed, the nutritional objective and information related to essential nutritional characteristics as laid down in column 1 and 2 of Commission Directive 2008/38/EC. For dietetic feed, indicate that The opinion of a nutrition expert or veterinarian should be sought before using the feed or before extending its period of use. and describe any additional particular that would be required in column 6 of Directive 2008/38/EC. For dietetic feed, the recommended period of use indicated in column 5 of part B indicates a range within which the nutritional purpose should normally be achieved. Manufacturers can refer to more precise periods of use, within the fixed limits. b) Minimum storage life (Use before date / Best before date): The minimum storage life means the period during which, under proper storage conditions, the person responsible for the labelling guarantees that the feed retains its declared properties; the minimum storage life shall be indicated in respect of the feed as a whole, based on the minimum storage life of each of its components. The setting of the best before date is the responsibility of the person responsible for labelling and shall take into account deterioration of certain elements of the compound feed such as vitamins. The determination of compound feed storage life should take into account (amongst other factors) the storage life of its different components (feed additives, feed materials as relevant) as specified by the supplier(s) of the component(s). The minimum storage life will be expressed as use before date or best before date depending on the perishability of the compound feed. - The use before date is mainly used for microbiologically perishable products (e.g. for liquid compound feed). The R. 767/2009, Art. 17(d) 11
numeric indication of dates shall follow the order of day, month and year and the format shall be indicated on the label by means of the following abbreviation: DD/MM/YY. - The best before date is used for types of compound feed other than microbiologically perishable ones. It is determined taking into account the best before dates of the constituents (feed additives, feed materials) and the specificities of the compound feed (e.g. presentation). The numeric indication of dates shall follow the order of month and year and the format shall be indicated on the label by means of the following abbreviation: MM/YY. The manufacturing date (day, month and year) may be mentioned on the label. In such case, the use before date or the best before date as appropriate can be indicated as follows: (period in days or months as appropriate) after manufacturing date. 3.1.3. Compound feed specifications a) Declaration of feed materials: (i) General principles Given that compound feeds are produced on the basis of the percentages of incorporation of each feed material on a weight basis and not on the basis of the moisture content of the compound feed, it is appropriate for technical and control reasons to list the feed materials incorporated into a compound feed in descending order by weight as included. The list of feed materials shall bear the heading Composition and shall indicate the name of each feed material. When a feed material with a high moisture content is incorporated in the compound feed (such as for a liquid compound feed), it is suggested - at the purchaser s request - that information is provided on the quantitative composition of the compound feed on a dry matter basis. The possibility for feed manufacturers to indicate percentages of all feed materials incorporated into a compound feed on a voluntary basis is intended to give an incentive to feed manufacturers to provide purchasers with additional product information. It is therefore recommended to favour the use of a range of +/- 15% of the actual value so as to grant sufficient know-how protection while ensuring a comprehensive and meaningful flow of product information to the purchasers. If the presence of a feed material is emphasised on the labelling in words, pictures or graphics, in particular in the commercial name of R. 767/2009 Art. 17(1)(e) R. 767/2009, Art 12
the compound feed, the name and percentage by weight of this emphasised feed material shall be indicated. For dietetic feed, describe the feed materials where the declaration is mandatory in accordance with column 4 of Directive 2008/38/EC together with percentage of inclusion. The declarations required in column 4 of Part B with the reference if added are compulsory where the feed material has been incorporated or increased specifically to enable the achievement of the particular nutritional purpose. (ii) Names of the feed materials: The person responsible for the labelling shall ensure that the names used to declare feed materials under the Composition headline are not misleading for the purchaser and comply with the general labelling principles. It is recommended to use the name of feed materials listed in the EU Catalogue of feed materials (Regulation (EC) No 68/2013) as referred to in Article 24 of Regulation (EC) No 767/2009. Using a name of a feed material listed in the Catalogue requires compliance with all relevant provisions for the specific feed material as laid down in the Catalogue (in particular description). It is required that the name of feed materials provided by the supplier on the feed material label, if listed in the Catalogue of feed materials, must meet the Catalogue requirements and therefore may be used by the compound feed manufacturer when declaring feed materials on the compound feed label. When declaring the composition of a compound feed, the person responsible for the labelling may supplement the name of a feed material listed in part C of the Catalogue of feed materials with additional information, e.g. trade name. In such a case, the additional information should be provided between brackets directly after the denomination used in the Catalogue. (Example: soybean meal (Hypro)). The person responsible for labelling may use a name not listed in the Catalogue of feed materials because he wants to use a more descriptive name (e.g. a brand name) or where the specific feed material does not align well with existing descriptions given in the Catalogue. In such cases, it is required that the name of the feed material is not misleading. It is recommended to include in the denomination of the feed materials a reference to the process undertaken as appropriate. Feed materials declared on the compound feed or the feed materials label under a name not listed in the Catalogue of Feed Materials shall have been notified to the register of feed materials (www.feedmaterialsregister.eu). When a compound feed contains one or several genetically modified (GM) feed materials (e.g. GM soya) or feed materials of GM origin 17(2)(a) R. 767/2009 Art. 11(1) R. 767/2009 Art. 24(5) 13
(e.g. soybean meal from GM soya), the GM origin of the feed material shall be mentioned along the following principles: - For feed materials which contain or consist of GMOs, the words genetically modified [name of the organism] shall appear either in parentheses immediately following the specific name of the feed material or as a footnote in immediate proximity to the declared composition. In all cases, reference to the GM nature of the feed material shall be printed in a font of at least the same size as the list of feed materials. - For feed materials derived from GMOs, the words produced from genetically modified [name of organism] shall appear either in parentheses immediately following the specific name of the feed material or as a footnote in immediate proximity of the declared composition printed in a font of at least the same size as the list of feed material. - If appropriate, labelling particulars must comply with additional requirements referred to in the individual authorisation decision of the GM events related to the characteristics of the feed (composition, nutritional properties, intended use), implications for the health of certain animal species, characteristics or properties where a feed material may pose ethical or religious concerns. The individual authorisations for GMOs may be found at the following link: http://ec.europa.eu/food/dyna/gm_register/index_en.cfm. R. 1829/2003 Art. 25 b) Declaration of feed additives: Feed additives must be declared under the heading Additives as appropriate with the most suitable unit of quantity referred to in the additive authorisation. Next to the heading Additives, it is recommended to include per kg or per litre in brackets as appropriate. Name, added amount and identification number of the following additives and name of the functional group or the category of the following additives shall be declared: - Additives where a maximum content is set for any kind of target species; - Zootechnical additives and coccidiostats and histomonostats; - Additives belonging to the functional group of urea and its derivatives of the category nutritional additives as laid down in Annex I to Regulation (EC) No 1831/2003; - Other feed additives requiring mandatory declaration according to their authorisation act (e.g. Hydroxy Analogue of Methionine (MHA) and its various forms authorised as a feed additive). Some or all other additives may be declared voluntarily. In this case, the name should be provided as well under the heading Additives and other information such as added amount or ID number may also R. 767/2009 Art. 15(f) R. 767/2009 Annex VI Chapter I (1) R. 469/2013 R. 767/2009 Annex VI Chapter 14
be provided. However, in case of voluntary declaration of the presence of a sensory or a nutritional feed additive, its added amount shall be included. For flavouring compounds, the list of additives may be replaced by the words mixture of flavouring compounds together with the added amount of the mixtures of flavouring compounds if none of the flavouring compounds present in the mixture are subject to limitation in the complete feed, i.e. to mandatory declaration. Operators should carefully consult the specific labelling requirements laid down in individual authorisation acts of each feed additive, accessible via the Community register of feed additives. There is no specific order imposed by the legislation regarding the listing of feed additives. The name of the feed additives shall be the one mentioned in the relevant legal act authorising the feed additives. These names may be found in the legal act authorising the feed additive, accessible via the Community register of feed additives. The name of functional groups or categories shall be as described in Annex I to Regulation (EC) No 1831/2003. Feed additives belonging to the same categories or functional groups should be described together so that the name of the category/functional group is mentioned only once. The name and added amount of a feed additive shall be disclosed if its presence is emphasised on the labelling in words, pictures or graphics. The amount to be declared shall be the amount added at the point of addition. This is important in particular for certain feed additives where the amount can be affected by the processing or decreases naturally over time, such as for vitamins or antioxidants. If a feed additive is authorised for more than one functional group, the functional group or category appropriate to its principal function in the case of the specific compound feed shall be indicated. If a feed additive is a GMO or is produced from a GMO in accordance with Regulation (EC) No 1829/2003, or contains a carrier of GM origin the labelling particulars mentioned above for feed materials shall apply. c) Analytical constituents The information on the nutritional value of the compound feed varies depending on animal species and shall be disclosed in accordance with Annex VI chapter 2 of the Regulation. It is recommended to describe them together under a heading Analytical constituents. In addition, the moisture content shall be disclosed under the same heading where it exceeds: - 5% in the case of mineral feed containing no organic substances, - 7% in the case of milk replacer feeds and other compound feed I (4) and (5) R. 767/2009 Annex VI Chapter I (2) R. 767/2009 Annex VI Chapter I (6) R. 1829/2003 Art. 25 R. 767/2009 Annex VI Chapter II 15
with a milk-product content exceeding 40%, - 10% in the case of mineral feed containing organic substances, - 14% in the case of other compound feed. The level of ash insoluble in hydrochloric acid shall not exceed 2.2% of the dry matter. Provided that it is indicated on the label, the 2.2% level may, however, be exceeded for: - compound feed containing authorised mineral binding agents, - mineral feed, - compound feed containing more than 50% of rice or sugar beet byproducts, - compound feed intended for farmed fish with a fish meal content of over 15%. For dietetic feed, the analytical constituents where declaration is mandatory in accordance with column 4 of Directive 2008/38/EC shall be described together with the total amounts. The declarations required in column 4 of Part B with the reference if added are compulsory where the additive has been incorporated or increased specifically to enable the achievement of the particular nutritional purpose. In addition, the amount of additional analytical constituents listed in column 4 of the Annex of Directive 2008/38/EC shall also be described. If the energy value and/or protein value are indicated, such indication shall be in accordance with the EC method if available, or with the respective official national method in the Member State where the compound feed is placed on the market, if available. When amino acids, vitamins and/or trace elements are indicated under the heading of analytical constituents, the amount to be declared shall be the total quantity of the amino acid, vitamin or element (e.g. copper) provided by feed materials and feed additives present at the end of the minimum storage life and that can be analysed by the official method of analysis when available. The amount of methionine declared as analytical constituent shall include the amount of methionine provided by feed materials and by any forms of DL and/or L methionine authorised as feed additive, as relevant. It shall not include the amount of Hydroxy Analogue of Methionine (MHA) in any of its forms authorised as feed additives as the official analytical method for methionine (see page 24 in Commission Regulation (EC) No 152/2009) is different from the methods for the determination of the various forms of Hydroxy Analogue of Methionine. When the feed contains any form of MHA authorised as feed additives, the person responsible for labelling may provide under the Analytical Constituents Heading and on the top of the mandatory declaration of methionine additional information to reflect the overall methionine equivalent value of the feed taking into account the R. 767/2009 Annex I (5) Directive 2008/38/EC R. 767/2009 Annex VI Chapter II (3) R. 767/2009 Annex VI Chapter II (2) R. 469/2013 16
contribution of MHA in its different forms. Specific guidance on the voluntary declaration of the methionine equivalent value of the feed in case of addition of MHA is given in Annex V. Voluntary disclosure of calculated nutritional constituents other than energy or protein values (e.g. calculated content of digestible/available phosphorus) shall be made according to, and with reference to recognised official national and/or international tables/methodologies. In other cases, the opinion of an independent expert scientist in animal nutrition on the relevance of the calculated nutritional constituent is required. The used method must be verifiable by the competent authorities. Other analytical constituents disclosed on a voluntary basis shall be meaningful for the purchaser and be recognised as a valuable indicator of the nutritional value of the compound feed. This should be substantiated either by national legislation, public literature or an independent expert scientist in animal nutrition. The declared amount of the analytical constituents shall be verifiable by an EC method, if available or with the respective official national method in the Member State where the compound feed is placed on the market. In other cases, the opinion of an independent expert scientist in analytical methods is required. Tolerances for analytical constituents are established in Annex IV of the Regulation. The tolerance established for a feed additive is also applicable for the total amount of the substance present in the feed as native (endogenous) and added amount. For calculated nutritional values or equivalent values, the tolerance to be applied shall be determined on the basis of the tolerances applying to the different analytical constituents and feed additives on which the nutritional or equivalent value is calculated. For analytical constituents not mentioned in the Annex IV the competent authority may consider individual tolerances with regard to the correctness of the declaration. d) Claims Claim may be defined as any message or representation, which is not mandatory under Community or national legislation, including pictorial, graphic or symbolic representation in any form, which states, suggests or implies: the presence or the absence of a substance in a feed, a specific nutritional characteristic or process, and relates any of these to a specific function. 2 The claim is the essential medium for passing on information in relation to a compound feed to the purchaser to ensure an optimal and informed choice and use of the product. Advertising or promoting the company with no direct reference to a product is not regarded as a R. 767/2009 Art. 13 2 Inspired from the definition of claims laid down in Regulation (EC) No 1924/2006 on nutritional and health claims made on food 17
claim and is not covered by the present Code. Claims on a compound feed may be made in relation to specific characteristics of the compound feed itself or, to the presence of one or more feed materials / feed additives or to a function thereof. Using claims requires compliance with a number of obligations. The key principles are as follows: - The use of claims is subordinate to the fulfilment of certain conditions listed in Annex I. - Claims shall not attribute to the feed effects or characteristics that it does not possess or by suggesting that it possesses specific characteristics when in fact all similar feeds possess such characteristics. - Claims should be scientifically substantiated. - The person responsible for the labelling is responsible for the accuracy of the claims. Annex I provides detailed provisions regarding the nature of the claims and the requirements for substantiation. 3.2. Information available on purchaser s request 3.2.1. Quantitative declaration of feed materials The person responsible for the labelling shall make available to the purchaser, on request, information on the quantitative composition data within a range of +/- 15% of the value according to the feed formulation. The obligation to provide the purchaser with further compositional information applies without prejudice to the provisions laid down in Directive 2004/48/EC on the enforcement of intellectual property rights. It must be noted that, as a legal act not directly applicable in national legislation, the various provisions of this Directive may not be interpreted and enforced in the same way at national level. Guidance laying down further detailed information on how to implement in practice at national level the provision of Article 17(2) b is provided in Annex IV of this Code of Practice. R. 767/2009 Art. 17(2)b) 3.2.2. Declaration of feed additives other than those subject to mandatory labelling requirements For the additives not referred to in Annex VI chapter I (1) of the Regulation, the person responsible for the labelling shall make R. 767/2009 Annex VI Chapter 18
available to the purchaser, on request, the name, the identification number and functional group of feed additives for which there are no mandatory labelling requirements. The disclosure of the quantity is not required. For flavouring compounds, the list of additives may be replaced by the words mixture of flavouring compounds together with the added amount of the mixtures of flavouring compounds. It must be reminded that flavourings with maximum daily restrictions in the complete diet shall be declared on the label. 1 (3) 19
4. Listing and specificities of commonly used labelling information media 4.1. General principles All mandatory labelling particulars shall be given in their entirety in a prominent place on the packaging, the container, on a label attached thereto or on the accompanying document (when the compound feed is delivered in bulk), in a conspicuous, clearly legible and indelible manner, in the official language or at least one of the official languages of the Member State or region in which it is placed on the market. Recommendations to ensure legibility of the label are provided in Annex III. If a decision is taken to provide voluntary information, voluntary labelling particulars may be provided partly or totally on the label or other media. If provided on the label, attention should be paid to not overload the label and it is verifiable with an EC method or with the respective official national method in the Member State where the compound feed is placed on the market. Voluntary labelling information not provided on the label should preferably be collated on a single medium. Such additional information may be provided at the time of order or delivery at the latest, and made available by different means, e.g. by paper or electronically. A summary table with labelling particulars that have to be on the label or may be on the label, is given in Annex II. R. 767/2009 Art 14 4.2. Design of the label For compound feed, the label shall be attached to the packaging of the compound feed when sold in bags. When delivered in bulk, the compound feed shall be accompanied by a document containing all mandatory labelling particulars required by the Regulation and other relevant EU legislation. In order to guarantee the legibility and easy accessibility of the labelling information for the purchaser of the compound feed, it is recommended to use headings and sub-headings which are either mandatory or added on a voluntary basis where appropriate. R. 767/2009 Art 14 (1) and 11 (2) 20
4.3. Additional documents or media (paper, internet, telephone ) Additional and complementary documents or media may be used to provide additional information/advice to the user of the compound feed and/or to provide information required by the purchaser as provided for in Article 17 2(b) and Annex VI chapter 1, par. 3 of Regulation (EC) No 767/2009. When additional information regarding a batch (lot) as delivered is provided on a separate media than the label, the batch number of the lot shall be specified on the two media (i.e. label and second format) for purpose of of traceability of labelling information. 4.4. Distance selling There are different forms of distance communication (i.e. Internet or phone) where the simultaneous presence of the supplier and the consumer is not required for the conclusion of a contract between those parties. When the compound feed is offered for sale through this distance selling, the mandatory labelling particulars specified in Chapter III.1 of the present Code shall appear on the material supporting the distance selling or shall be provided through other appropriate means prior to the conclusion of the distance contract. The following particulars are exempted before the conclusion of the distance contract but shall be provided by the point of delivery of the feed: - the name or business name and the address of the feed business operator responsible for the labelling - the batch or lot reference number - the net quantity expressed in units of mass in the case solid products, and in units of mass or volume in the case of liquid products - the minimum storage life for additives other than technological additives - the indication of the minimum storage life. For packed feed, it is recommended to provide indication of the quantity of one unit (e.g. kg/bag). R. 767/2009 Art 11 (3) 21
ANNEES 22
Management Of Claims ANNE I Warning: the examples of claims mentioned in this annex are given for illustration purpose only and do not preclude of the lawfulness of their use which depends on circumstances and ability to justify. 1. Guidance on the implementation of Article 13 and Article 11(1)(b) of Regulation (EC) No 767/2009 on claims This annex of the Code provides guidance to the person responsible for the labelling on the development of and the presentation of claims. In this introduction of this annex it is meaningful to provide a delineation of claims in order to provide guidance and assistance to the operators, purchasers and the authorities. The following sections of this annex will provide further detailed guidance of the relevant aspect of development and presentation of claims 1.1. Basic conditions for use of a claim Claims are permitted providing that the following conditions are met: - The claim is objective; - The claim is verifiable by the competent authorities; - The claim is understandable by the user of the compound feed; - The claim is substantiated (further details in part 2 of the present annex ); - The claim is not misleading; - The claim is not prohibited. 1.2. Basic description of a claim Claims on compound feed may be made in relation to specific characteristics of the compound feed itself including the following properties of the compound feed: - Appearance / processing of the compound feed; - Composition of the compound feed (feed additives, feed materials or combinations thereof, including where relevant any specific processes undergone by the feed additives or feed materials); - Nutritional and/or analytical characteristics of the compound feed; - The function of the compound feed. As such, a claim can include reference to the nutritional nature and/or functional effect of the compound feed as well as its effect on animal performance, quality of animal products and 23
livestock management aspects provided that the claim is substantiated according to the criteria as specified in part 2 of the present annex and does not conflict with the following limitation: The labelling of the compound feed cannot include a claim that contains reference that the compound feed will prevent, treat or cure diseases, except for coccidiostats and histomonostats as authorised under Regulation (EC) No 1831/2003; this point shall not, however, apply to claims concerning nutritional imbalances provided that there are no pathological symptoms associated therewith. Claims in relation to functions listed in Regulation (EC) No 1831/2003 on feed additives may be made for compound feed when this function is exerted in the compound feed, whether this function is linked to the presence of an authorised feed additive for this function or to a feed material or a substance in a feed material or to the compound feed itself. Claims concerning optimisation of the nutrition and support or protection of the physiological conditions are permitted, with the exception of those listed in Article 13(3) of the Regulation. Where a claim can be made for a particular component, this claim can also be made for the finished product in which this component is included, provided that there is a clear connection between the claim and the component. Whenever the name of one or more feed additives and/or feed materials and/or analytical constituent is described in a claim other than referring to its absence, the names and total amounts of substances/products shall be indicated on the label under the appropriate heading. Feed additives shall be used for the purpose they are authorised for. Claims related to the presence of a feed additive shall relate to (one of) the function(s) corresponding to the functional groups indicated in the regulation authorising the additive providing that it is present at the level required in accordance with the authorisation. Claims concerning nutritional imbalances are permitted provided there is no pathological symptom associated therewith, except for claims related to feed for specific nutritional purposes, as long as the specific feed satisfies all relevant legal requirements (Directive 2008/38/EC). 1.3. Phrasing of a claim Feed may exert certain functions that are of clear benefit for animal health. However, depending on the way the claim is formulated, a product could be considered by public authorities either as a feed or as a (non-authorised) veterinary medicinal product. The wording of a claim is therefore extremely important and shall not, as required by the legislation refer to prevention, treatment or curation of a disease. This means in particular that: - Words such as supports, maintains, contributes, optimises, provides fosters, etc. would generally be acceptable. Words such as stimulates, increases, improves or reinforces may also be acceptable unless they refer to a certain physiological function; - Words such as dose, dosage, cures, treat, treatment, remedy, prevent, relieves, heals, etc. shall not be used; - Names of diseases are prohibited (except for feed for specific nutritional purposes, in accordance with authorisations of nutritional purposes (Directive 2008/38/EC)). 24